The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Accepted for cardiac valve intervention

Able to provide informed consent

Disqualifiers

Previous or ongoing infective endocarditis

Urgent surgery

Pain from loose tooth/teeth

Immunosuppressive therapy (excluding corticosteroids)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative dental screening

    Other intervention

    Dental examination prior to valve intervention; treatment performed if indicated.

  • No preoperative dental screening

    Other intervention

    No routine dental screening prior to valve intervention.

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: Preoperative dental screeningExperimental treatment 1 intervention
Group B: No preoperative dental screeningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite outcome of death, redo-intervention, or infective endocarditis

Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.

Time frame
2 years

Secondary outcomes

1

All-cause mortality

Time frame
2 years
2

Redo-intervention of index valve

Time frame
2 years
3

Definite infective endocarditis

Time frame
2 years
4

CIED extraction

Extraction of Cardiovascular Implantable Electronic Device (CIED)

Time frame
2 years

Other outcomes

Sponsors and contacts

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